在COVID-19患者中使用glenzocimab准GPVI:随机临床试验的结果
Julien Pottecher1, Francois Raffi2, Martine Jandrot-Perrus3,4
1Strasbourg University Hospital, UR3072, FHU OMICARE, FMTS, Strasbourg, France.
PloS one
|June 17, 2024
概括
针对血小板糖蛋白VI (GPVI) 的glenzocimab没有显著降低COVID-19 ARDS的临床进展. 然而,它在统计学上显著地降低了NEWS-2得分,并且在接受氨酸的患者中没有增加出血风险.
科学领域:
- 心血管研究研究心血管研究
- 免疫学 免疫学 免疫学
- 传染性疾病 传染性疾病
背景情况:
- 感染SARS-CoV-2会导致前血栓状况和肺部损伤.
- 机制包括凝血病,内皮功能障碍和血小板失调.
- 格伦佐西马布是一种新型抗血栓剂,向血小板糖蛋白VI (GPVI),而不会引起出血.
研究的目的:
- 为了评估glenzocimab在SARS-CoV-2呼吸衰竭患者中的疗效和安全性.
- 评估GPVI抑制在管理COVID-19相关的凝血病和肺损伤中的作用.
主要方法:
- 园林:一个随机的,双盲的,探索性第二阶段研究.
- 患有COVID-19呼吸衰竭的成年人接受了标准护理加上glenzocimab或安慰剂.
- 主要终点:在第4天的临床进展;分析了治疗意向人口.
主要成果:
- 在glenzocimab和安慰剂手臂之间,COVID-19 ARDS临床进展没有统计学上显著的差异 (43.3%与29.0%,p=0.245).
- 在glenzocimab手臂的第4天,NEWS-2类别的统计学显著下降 (p=0.0290).
- 没有与研究药物相关的严重不良事件;两臂之间可比的出血事件.
结论:
- 作为GPVI抑制剂的glenzocimab在接受肝素治疗的凝血病性COVID-19患者中是安全的,没有增加出血或SAEs.
- 该研究没有证明glenzocimab对COVID-19 ARDS的临床影响.
- 对其他形式的ARDS进行GPVI抑制的进一步研究是有必要的;glenzocimab正在研究中风和心血管征兆.
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